Siemens Recalls 29 Interventional Fluoroscopic X-Ray Systems for Shutdowns
Siemens is recalling 29 interventional fluoroscopic X-ray systems because the power supply may cause the computer to shut down unexpectedly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths. The hazard is a sporadic system shutdown, which is a functional defect rather than a direct physical injury risk, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 29 Interventional Fluoroscopic X-Ray Systems, specifically the ARTIS Icono biplane and floor models. The recall is due to a potential issue where the system's uninterruptible power supply (UPS) may sporadically force a shutdown of the imaging system's computer without an actual power supply problem.
The affected systems were distributed nationwide in the United States, specifically in the states of Michigan, Kentucky, and Texas. These systems are used for single and biplane diagnostic imaging and interventional procedures, including for pediatric and obese patients.
Hospitals and medical facilities should contact Siemens to arrange for a repair or replacement of the affected units. Patients and consumers should not attempt to repair the equipment themselves.
The recalled product
- Product
- Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
Distribution
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